Intra-uterine device



Oct. 17, 1939.

L. W. MECKSTROTH INTRA-UTERINE DEVICE Filed Jan. l5, 1936 2 Sheets-Sheet 1 [/7 Invento oct. 17, 1939.

. l.. w. MEcKsTRoTH 2,176,559

INTRA-UTERINE DEVICE Filed Jan. 13, 1956 2 Sheets-Sheet? [olf/'s WMecstro Inventor Patented Oct. 17, 1939 UNITED STATES PATENT OFFICE 8 Claims.

This invention pertains to anatomical devices, and more particularly to intra-uterine devices and capillary drains.

It is an object of this invention to provide a self-retaining capillary drain which readily accommodates itself to any cavity in which it is applied, and one which is comfortable as well as non-injurious to the wearer or user.

Another object is to provide an intra-uterine device wherein there is little or no tendency nor likelihood of the device being expelled from the uterus.

Still another object is to provide an intrauterine device which is vreadily and easily applicable to the uterus and retained in the uterus without any discomfort on the part of the patient.

Yet another object is to provide a non-irritating capillary drain adapted for use in any sinus for any pathological difficulty such as an abscess.

A further object is to provide an intra-uterine device which prevents matter foreign to normal secretions from remaining in the uterus.

A still further object is to provide an intrauterine device which relieves dysmenorrhea and amenorrhea, tending to normalize menstruation, and to correct causes of faulty menstruation, or lack of menstruation, and to prevent retention or stasis, and to help eliminate pathological secretions as well as normal secretions of the uterus.

Another further object is to provide an intrauterine device or capillary drain which is suiciently stiff and rigid to maintain its approximate shape under the pressure, warmth and moisture of the uterine cavity, yet is suiciently pliable or fiaccid to adapt itself to the conformation of the cavity walls without resistance and resultant injury to the tissues. v

A different object is to provide an intra-uterine device which, while readily introducible with a proper instrument by a competent physician or one skilled in the art yet, once applied, is effective and may be retained in the uterus without injury or discomfort to the uterus for an appreciable time and in no wise interfering with the normal functions in the adjacent vagina, the device being readily removed by anyone, such as the patient.

Still a different object of the invention is to provide an intra-uterine device which may be retained on the introducer therefor by a sterilized, germicidal capsule which aids Vinsertion into the uterus and is readily dissoluble to permit release of the device from the introducer.

Another different object is to provide an intrauterine device having a looped head which has members of the general angularity of the uterine cavity.

A further different object is to provide an intrauterine device readily suitable to application to the uterus by means which actively. prevents con- (Cl. 12S-130) tamination of the uterine cavity from infected or foreign matter in, or introduced into, the cervix or vagina.

With these and various other objects in view, the invention may consist of certain novel features of construction and operation as will be more fully described and particularly pointed out in the specification, drawings and claims appended hereto.

In the drawings, which illustrate embodiments of the device and wherein like reference characters are us-ed to designate like parts- Figure 1 is av plan View of a form of intrauterine or drain device embodying the invention;

Figure 2 is an enlarged fragmentary sectional plan view of the appendage and a portion of the associated head of the device illustrated in Figure 1;

Figure 3 is a fragmentary plan View of a modified form of drain;

Figure 4 is an enlarged fragmentary sectional plan view of the appendage of the device illustrated in Figure 3;

Figure 5 is a sectional elevation of a uterus taken longitudinally of the uterine cavity illustrating the application thereto of the intra-uterine device illustrated in Figure 1;

Figure 6 is a side elevation of a form of introducer having the device assembled therewith for introduction into a sinus or other cavity;

Figure '7 is a top plan view of the introducer illustrated in Figure 6 showing the device applied thereto, but before application of the retaining cap to complete the assembly of the device with the introducer.

The drain or intra-uterine device illustrated herein consists essentially of a head, an appendapplicants co-pending application Serial No.l

730,411., led June 13, 1934, now Patent No. 2,122,579.

Referring particularly to the construction of the device illustrated herein, the head 3@ is formed of a single elongated member such as a piece of silkworm gut looped to proper shape and impregnated with antiseptic material. The head 3] is looped so that the portion 32 is formed on an arc, being sharply bent at 3d to merge into the slightly arcuate or substantially straight portion 36, said portion and the similar adjacent portion 38 being separated by the sharply angled portion 40 disposed substantially in alignment with the appendage 42. The portion 38 is sharply angled or bent as at 44, merging into. an arcuate portion 46 similar to the portion 32. The ends 48 and ping 52 are covered by a woven silk tube 56 eX- tending the proper length to form the appendage 42, and on this tube is applied a penetrating or liquid or water proof flexible cement which eX- tends for the length of the appendage and covers the end, sealing cement 58 thus totally sealing the splice in the appendage. The penetrating cement may have a covering of vulcanizing material as rubber over which there is applied a flexible varnish or penetrating liquid forming a smooth highly finished member.

Forming the head with the angular portion such as shown facilitates assembly of the device with the introducer, and also provides a device which more comfortably occupies the triangular cavity 5i! of the uterus 62 as shown in Figure 5, it being seen that the head 35 readily conforms to the shape of the cavity El), and it is noted that the spaces between the head and the cavity tissues are exaggerated to more clearly illustrate the position occupied by the device.

The appendage 42 lies in the cervical canal 64, and the withdrawal loop 54 extends outwardly of the cervix 65 where it will lie in the vagina and thus render the device readily accessible when it is withdrawn for any reason, such as to be renewed. The appendage 42, while it is flexible, is relatively stil with respect to the head 38, and thus will conform to the cervical canal to correct any stricture or flexion, create a normal opening, and correct menstrual an'd other difliculties, all as particularly described'in the above identi co-pending application,

The modification shown in Figures 3 and 4 illustrates a .device wherein a shorter appendage is utilized. The head in this case is the same as already described in Figure 1, and the same reference characters are used to designate similar parts. In this form of the device the ends 48 and 50 are secured side by side by means of the threaded wrapping 352 which is likewise looped as at 354 to provide suitable withdrawal means. The ends thus secured are covered with an appendage indicated generally at 342, said appendage being small and preferably formed by an inner covering or layer of plastic cement 356 and an outer covering 358 of an impervious finish such as a fiexible varnish.

Referring now more particularly to the introducer illustrated in Figures 6 and '7 as being suitable for use in applying the devices described supra, said introducer 68 consists essentially of a metallic rod of small enough diameter to be readily insertable through the cervical canal, said rod being preferably arcuate in' side elevation as shown in Figures 6 and 8. Said rod is provided with the handle end lll and the head 'l2 which is notched as at T4 for the reception of the head 30 of theintra-uterine device,and said rod is provided adjacent the head with a depressed or cut out portion 'F6 of sufficient depth to readily accommodate the appendage 42 without greatly increasing the over-al1 diameter of the assembled device and introducer.

In assembling the intra-uterine device on the introducer such as shown particularly in Figures 6 and 7, the slotted end 'I4 is disposed so that the notch 'I4 will engage the head at the interlacedv portion 'I8 of said head, the depressed or' flattened portion 76 being disposed below the head 30 whereby the opposite interlaced portions B0 and 82 lie above said flattened portion. The loop 54 may then be ydisposed to extend below or within the arc of the introducer, such as particularly shown in Figure 6. By pulling the withdrawal thread 54 toward the handle end lil, the head `is elongated to such an extent that the angular portions 34 and 44 are disposed within the notch 14.

To maintain the assembly, a gelatin cap 84 is provided of such diameter that it will form a substantially tight t with the head, further depressing the sides of the head 3U, and not overly increasing the dameter of the assembled introducer and device. The length of the cap is sufficient to cover any angular or sharp portions of the head of the device. The cap and head are preferably sterilized and rendered germicidal to surrounding uids and tissues by impregnation with a germicide which may include iodine or acri-avine, which are strongly antiseptic and rela-tively non-toxic. It is also contemplated that additional antiseptic material might be provided within the assembled cap, or an antiseptic jelly might be disposed in the cap, or the cap might be dipped in either. Thus, as the cap dissolves quickly, the device is self-sterilizing and actively germicidal. The applied device, being also impregnated with antiseptic, also gives ofi" antiseptic for several days after application, which is desirable, as the cervical cavity is naturally nonsterile, while the uterine cavity is naturally sterile. Thus, by impregnating the device with any antiseptic material such as the above ingredients, contamination is prevented, as any infected material carried from the cervix or uterus into the cavity 6U will be sterilized.

From the above it will be appreciated that there is provided a self-retaining drain designed for the drainage of cavities, particularly those with a narrow outlet, such as abscess cavities, natural anatomical cavities and hollow organs, which require drainage to counteract infection, obstruction or accumulation of fluid and tissue cells.

The ordinary abscess cavity is formed by a collection of pus in the tissues and is Vlined with cellular elements. The natural anatomical cavities, such as nasal sinuses, and cavities of hollow organs, as the uterus, bladder and kidney pelvis, are also subject to pusinfection and are an illustration of such infection Vin pre-formed natural cavities lined with a mucus 'membrana which membrane becomes engorged and thickened with enlarged blood vessels, and infiltrated and covered with red granular cells, which if allowed to continue eventually result in scar tissue, with destruction of the normal mucus membrane( The self-retaining drain herein described is suitable to the correction of these conditions by virtue of its self-retention over long period without injury, facility of medication and drainage, controlling infection and engorgement, the damming back of fluids, and the growth of cellular tissue within or on the mucus membrane or abscessed wall.

The head or self-retaining member as indicated is made of a shape, size, material and form to properly fit the cavity for which it is intended and to conform to such cavity by its yielding, pliable nature, without harmful pressure, but of a construction to become surrounded by, or to penetrate, accumulations of soft cellular tissue which it is desirable to remove, by causing canalization and fragmentation, designated as filament canalization and fragmentation, and giving entrance to body fluids which digest and liquefy and make for ready drainage.

Attached to or continuous with the retaining member is a drain portion or appendage of a size and length to suit the individual case and to occupy the narrower outlet of the cavity. The appendage may be solid or hollow and it may have an opening or openings at the proper places for the introduction of medication, without removal of the entire drain device.

While the device may be made in various dimensions, forms, shapes, multiplicity of parts, etc., hollow or solid drain, it is convenient to describe it, as applying to the uterus, as 'covering its general application and also some special applications peculiar to the uterus, having to do with control and relief of certain menstrual disorders in which the normal physiologic processes in the mucus membrane of the uterus (menstrual membrane) closely imitate the conditions of infection as described. These changes constitute a menstrual cycle and consist of a post-menstrual period of healing and rest followed in succession by congestive conditions of the blood vessels, thickening, engorgement, and deposit of cellular tissue, and finally digestion, liquefaction, exfoliation and shedding of these products, accompanied by bleeding and constituting the menstrual period, the conclusion of which marks the end of the cycle, all of which resembles an automatic self-healing, inflammatory or infective process.

This cycle of events is usually without symptoms. Some of the exceptions which call for relief are amenable to correction by this device on a principle similar to that in infections. These conditions are:

(1) Dysmenorrhea (painful menstruation).

(2) Amenorrhea (absence of menstruation).

(3) Prolonged menstrual cycles (deferred menstrual periods).

Dysmenorrhea is relieved by filament canalization and fragmentation, self-digestion and liquefaction and ex-foliation of tissue cells and menstrual membrane, drainage, and the correction of obstructive conditions. Amenorrhea and prolonged menstrual cycles are relieved first by the activating presence of the filament member, promoting normal activity of a sluggish mucus membrane, and later encouraging ex-foliation and menstruation by filament canalization and fragmentation of the soft, cellular intra-uterine material, with resultant auto-digestion, liquefaction and easy expulsion.

Inflammatory and infectious conditions are characterized by similar phenomena of those of the menstrual cycle with the exception that they are caused by infection from pathogenic or disease producing germs, and besides congestion, swelling, and thickening of the mucus membrane and deposit of cellular tissue, there is a free accumulation of pus and mucus which requires drainage and medication for its relief and cure.

The function of the drain is the same in each of the above cases, namely, self-retention, fragmentation and canalization of cellular deposits, drainage, relief of obstruction, and relief of accumulations of pus and mucus, and medication.

This description can also apply by analogy to the conditions of infection of other hollow organ cavities, natural anatomical cavities, and t'sue abscesses.

It is to be understood that I do not wish to be limited by the exact embodiments of the device shown, which are merely by way of illustration and not limitation, as various and other forms of the device will of course be apparent to those skilled in the art without departing from the spirit of the invention or the scope of the claims.

I claim:

1. In a device of the character described, the combination of a head of accid material adapted to accommodate itself to body tissues, an appendage including a tubular member secured to said head, and means secured to said appendage for extracting said device from the body.

2. An intra-uterine device including a looped pliable head adapted to accommodate itself to the cavity walls of the uterus, each of the looped portions of the head having angularly disposed portions forming substantially a sharp apex, a

relatively stiff appendage portion connected to said head and adapted to lie in the cervical canal, and means attached to said appendage and adapted to lie in the vagina to form withdrawing means for said device.

3. A substantially pliable accid intra-uterine device including a head comprising a loop, and an appendage secured to said head, said loop being so formed that an apex is disposed adjacent one extremity thereof, the axis of said loop extending at an angle to the axis of said appendage whereby said apex will lie toward a corner of the uterus when the device is in the uterus.

4. An intra-uterine device including a head comprising a plurality of looped portions, an appendage secured to said head, each loop being so formed that a substantially sharp apex is disposed adjacent one extremity thereof, the joining portions of said loops being angularly disposed.

5. An intra-uterine device comprising a pliable flaccid head, said head having a substantially sharp apex, an appendage secured to said head, said appendage being relatively small and elongated, a portion of said head being adapted to be encased in a readily removable, meltable casing.

6. An intra-uterine device including a pliable accid head having spaced lobes connected at an angle, each of said lobes having a substantially sharp apex and an appendage connected to said head.

'7. An intra-uterine device including a pliable head having spaced lobes connected at an angle, an appendage connected to said head, said appendage including a wrapping connecting 'adjacent portions of said head, a woven silk tube covering said wrapping, a liquid-proof flexible l 

